Astero StarFish

Using CM&S to Improve Medical Device Development

Most engineers use computational methods to simulate engineering phenomena when developing medical devices. Computational modelling and simulation (CM&S) has been used for decades as an assistive tool for medical device design and development.
Our analysis group uses Ansys CM&S software to investigate fluid dynamics, structural, thermal, electro-magnetic, fluid-structure interactions, and other multiphysics problems. In many instances, evidence has also been gathered for submission to regulatory bodies, assessing portions of the design and providing evidence to confirm its safety and efficacy. This blog shares real-world examples from engineers using the analysis group CM&S to improve their medical device development.

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Nathan Müller

Medical Device Vibration Analysis and Testing Reduce Risk

Medical Device Vibration Analysis Modal Analysis
The effect of vibration on medical devices can be understood through a combination of vibration analysis and testing. This blog discusses the medical devices most susceptible to vibration, basic theory and methods of vibration analysis, and the benefits of using modal analysis in the development of medical devices. Modal analysis, the most fundamental portion of vibration assessment, can inform design decisions for critical component placement and overall device implementation due to the mode shapes and natural frequencies it quantifies.

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Dhruvitha Krishna

FDA Guidance on Computational Modeling and Simulation in Medical Device Submissions

CM&S Medical Device Submissions FDA Guidance The FDA’s Modeling & Simulation (M&S) Working Group of the Senior Science Council has noted that the use of Computational Modeling and Simulation (CM&S) is expected to increase in the future years, in a report outlining the Successes and Opportunities in Modeling & Simulation for FDA. FDA has recognised the importance of using CM&S in medical device development.
This article summarizes the FDA Guidance Document “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (17th November 2023)”.

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Disha Patel

12 Steps to Set up a Biomed Lab

12 Steps to Set up a Biomed LabSome lab managers get to manage a running lab, but others get a whole new challenge of being a lab manager where there is no lab yet. Each phase from having nothing to having everything in operational condition requires thoughtful decision making and involves professionals from various backgrounds.

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Brian King

10 Tips for Medical Device Optical-Breadboard Prototypes

Medical Device Optical-Breadboard PrototypesWhen designing a medical device made of complex, multi-functional mutually interacting subsystems it’s best to de-risk those subsystems instead of coming up with a paper design, assembling it, and hoping it works first time. De-risking individual subsystem behaviours one at a time enables more-focused assessments and improves troubleshooting.
For an optical subsystem, this de-risking is often conveniently performed using optical breadboards or cage systems – the optical-prototyping equivalent of LEGO® or TINKERTOY®.

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Astero StarFish

14 Ways to Increase Medical Device Speed to Market

Medical Device Speed to MarketWithout sacrificing safety or quality

Speed to market is a crucial part of medical device success. Our employee experts drew upon their experience with hundreds of medical device products for proven tips and recommendations that increase medical device speed to market without sacrificing safety or quality.
Read on to discover how to understand the intended market, focus the development process, and pay early attention to regulatory requirements and design transfer can speed the medical device commercialization journey.

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Astero StarFish

Commercializing Medical Devices with Optics

Commercializing Medical Devices with OpticsCommercializing a medical device with optical components brings a unique set of challenges. We asked our multi-disciplinary team of engineers, regulatory, manufacturing and optics experts to share their experiences and lessons learned for commercializing medical devices with optics components and interacting with optics engineers.
Learn what they pay attention to and how they change behavior from commercializing medical devices without optical components.

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Ryan Field

A Comparison of Detection and Imaging Methods Used in Optical Coherence Tomography

Optical Coherence Tomography TypesOptical coherence tomography (OCT) is an imaging technique with many current and potential applications in medical devices. The most common medical uses of OCT are in ophthalmology and optometry, in which OCT is commonly used to take cross-sectional or 3D scans of the eye’s anterior and posterior segments. Other areas of active development include dentistry, dermatology, and gastroenterology [1, 2, 3].
This blog discusses the various types of OCT and some of the imaging techniques they use, with a brief overview of some advantages and disadvantages of each.

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James Sease

The Value of SBOMs and SBOM Analysis

SBOM Analysis and Value
The FDA recently published a new guidance on Cybersecurity and software in medical devices: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”.
The new guidance has pushed software composition and vulnerabilities up in importance when making a submission to the FDA. As such, Software Bills of Materials (SBOMs) have become a required output for all submissions.

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Dendy Addison

Creating a Medical Device Bootscreen for QNX

QNX Medical Device Bootscreen
Most if not all major devices (including medical devices) throughout the world have some form of a bootscreen. This often flashy but sometimes simple animation performs two purposes. One is simply that it looks good, plus companies can personalize and add their branding to it. But the second reason is arguably more important; it lets the user know that the device is working and currently still in the start up phase.
This blog will get very technical as it describes how to design and create a bootscreen.

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